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ID
Source
Brief title
Health condition
Vaginal birth
Sponsors and support
Intervention
Outcome measures
Primary outcome
Usage of epidural analgesia during labor
Secondary outcome
referral from primary care tot secondary care, percentage caesareans, percentage instrumental deliveries, adverse outcomes from epidural (in general fever, augmentation of labor, prolonged labor, postpartum hemorrhage, hospitalization of mother and/or newborn), cost-effectiveness, budget impact analysis and patient satisfaction.
Background summary
Background
To improve perinatal outcome, in 2009 the Steering Committee for Pregnancy and Childbirth in the Netherlands advised to implement continuous care during labor, although clear data on cost effectiveness are lacking. Despite a marked rise in the use of epidural anesthesia, current obstetrical caregivers are not able to supply continuous care for more than 70% of women. In the Dutch system, maternity care assistants supply care during the last stages of labor and the question is whether to extent care to a longer period of time would be a cost effective intervention.
Methods
We propose an RCT on continuous care compared to care as usual. All multiparous and nulliparous women with an intention to a vaginal delivery, with understanding of the Dutch language and > 18 years of age can be included. The intervention consist of continuous care by a trained maternity assistant (MA) from the moment the obstetrical caregiver states labor has started.
The primary outcome will be use of epidural analgesia. Secondary outcomes are mode of delivery, complications, patient satisfaction and cost effectiveness which will be calculated by QALY per prevented EA based on utility index from the EQ-5D and usage of healthcare. Standardized sensitivity analysis will be done to quantify the outcome and a budget impact analysis will be done . In order to show a reduction from 25% to 17% in the primary outcome 2x496 women are needed
Study objective
Continuous care during labor by a maternity care assistant will reduce the usage of an epidural and will reduce complications and is therefore costeffective and increases patient satisfaction about their labor experience
Study design
Inclusion started 30-08-2018
Intervention
Continuous support during labor from the moment midwife states labor has started by a maternity care assistant
Inclusion criteria
Planned vaginal birth
Women from 18 years or older
Pregnancy in third trimester
Living in the region of south Limburg
Exclusion criteria
Planned caesarean
Not able to read informed consent (knowledge of Dutch language)
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8065 |
| CCMO | NL51853.068.17 |